There are no guarantees with the Food and Drug Administration (FDA)’s personal importation process. You cannot apply for permission to import insulin, then have your badge of approval, for unlimited importation of animal insulin.

Instead, you order it from a foreign company, have it shipped to you with all required documents in the package, and hope that U.S. customs and FDA authorities let it reach your door.

Personal importation means that only you will use it and you will not sell the product to anyone else. Only a three-month supply of insulin (or any medication) is allowed under the FDA’s personal import policy.

“An imported product doesn’t have the right to enter the country. It’s a privilege,” says Brad Williams, director of the FDA division that handles personal importation.

According to Williams, the rules come from Washington, but local FDA district offices throughout the United States make decisions on what is allowed.

“A product arrives in the United States with a customs declaration on it, either by mail or you’ve brought it back yourself on a plane,” explains Williams. “Forms are filed into the customs computer, and the ones that are FDA-regulated products get sent to a section of the computer that lists it out for us.”

FDA inspectors look at that computer list, and randomly pick packages to be further examined. They judge if the packages will reach their final destinations. The FDA district inspectors have offices in major airports and in the hubs of big shipping companies like FedEx and DHL.

Not every single package gets inspected, admits Williams.

“Frankly, due to the volume-we are pretty good at it-but we’re not 100 percent on imports,” Williams says. “You’ll hear people say, ‘But I got that in.’ Well, that’s because one day there were 10,000 entries going through the same computer, and the next day, when yours came in, there were only 100.”

If a package is examined, it must have the proper paperwork. Most important is a letter from a doctor stating your need for animal insulin.

“With your 90-day supply, you have a letter outlining your situation, with a note from your doctor stating that he’s working with you on this therapy,” says Williams. The letter should state that human insulin is not working for you, and that you need animal insulin.

If you don’t have this letter, you will get a notice by mail informing you that your package is being detained by the FDA.

“It would be called a notice of detention and hearing,” explains Williams. “It would say, ‘I received your box of X and I propose to detain it, and hold a hearing as to why we shouldn’t destroy it.'”

You can also choose to keep your doctor’s letter in your possession, instead of sending it with your order. In this case, Williams says, it will be detained because the documents are not there, but when you get the notice that the FDA is detaining the package, you can explain your situation with the district and work with them. CP Pharmaceuticals, however, strongly advises that this letter be included with an order, to smooth its entry into the United States.

Based on its communication with the FDA, CP Pharmaceuticals also recommends including the prescription form for the insulin, showing the physician’s name, address and telephone number.

Your Own Statement

Williams does not mention a personal statement, but CP Pharmaceuticals reports that the FDA advises writing your own letter. You should sign a letter stating your name, address and telephone number, and that the insulin is for personal use and only constitutes a three-month supply.

USDA Form

According to CP Pharmaceuticals’ Web site, because beef insulin comes from cows, the United States Department of Agriculture (USDA) is involved, along with the FDA. You need an “Application for Permit to Import Controlled Material or Transport Organisms or Vectors.” You need to fill it out, send it back to the USDA, and the agency will send you a permit. Send a photocopy of this permit with your insulin order form and shipment. Get the form by calling the USDA at (301) 734-3277.

Then, Wait

With all the proper documentation, will your insulin get to you? It is up to the FDA district.

“For the most part, the districts are pretty open about letting people bring things in,” Williams reports. “Sometimes there are problems, so you’re not always going to have a smooth ride, and there are some general rules that have to be followed.”

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